- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT05126745
Assessment of Catheter Flow Direction Using Color Flow Doppler in Labor Epidurals
Assessment of Catheter Flow Direction Using Color Flow Doppler in Labor Epidurals: an Observational Study
Epidural analgesia is commonly used for pain relief in labor and involves placement of a catheter in the epidural space. Failure of epidural analgesia may occur in 12-16% of epidural catheter placements. It is defined as inadequate analgesia after the local anesthetic loading dose, despite use of appropriate dose/concentration of local anesthetic. Failure to provide adequate epidural analgesia is commonly caused by malposition of the epidural catheter. Many factors may influence the position of the tip of the epidural catheter and the resulting spread of local anesthetic into the epidural space, and consequently the quality of analgesia. Previously, X-ray exposure was required to assess catheter position in the epidural space. Recent developments have allowed the anesthesiologist to assess the catheter position at the bedside after its placement, using color flow Doppler ultrasonography.
The investigators will perform an observational study to determine epidural catheter flow direction in the obstetrical population using color flow Doppler ultrasound. Women who have delivered under epidural analgesia, either vaginal or caesarean delivery, will be approached for the study before the epidural catheter is removed.
The investigators aim to determine epidural flow relative to the insertion site, describe the findings and to correlate them with other clinical outcomes.
Studieoversigt
Status
Betingelser
Intervention / Behandling
Undersøgelsestype
Tilmelding (Faktiske)
Kontakter og lokationer
Studiesteder
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Ontario
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Toronto, Ontario, Canada, M5G1X5
- Mount Sinai Hospital
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Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Prøveudtagningsmetode
Studiebefolkning
Beskrivelse
Inclusion Criteria:
- Women who have delivered under epidural analgesia
- Women who have vaginal or caesarean delivery
- Women with the epidural catheter still in place
Exclusion Criteria:
-Women who experience fetal or maternal complications during delivery
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
Kohorter og interventioner
Gruppe / kohorte |
Intervention / Behandling |
|---|---|
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Patienter, der havde en epidural anbragt til fødsel
Patienter, der har fået anbragt en epidural til fødsel, kan deltage.
Undersøgelsesprocedurer vil finde sted efter fødslen og før fjernelse af epiduralkateteret.
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Doppler ultrasonography
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Visualization of flow relative to the interspace insertion level as assessed by color flow Doppler ultrasound
Tidsramme: 15 min
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Visualization of flow relative to the interspace insertion level as assessed by color flow Doppler ultrasound (at insertion level [yes/no], above insertion level [yes/no], below insertion level [yes/no], no visualization of flow in any space).
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15 min
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Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Level of epidural catheter insertion: questionnaire
Tidsramme: 5 min
|
The anesthesiologist will record the intervertebral level at which the epidural was placed: L2-L3, L3-L4
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5 min
|
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Epidural regimen: questionnaire
Tidsramme: 5 min
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Settings for the epidural pump as charted by the anesthesiologist and the nurse.
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5 min
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Maximum upper sensory block to ice: questionnaire
Tidsramme: 5 min
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Maximum upper sensory block to ice as charted by the nurse in the electronic charting system
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5 min
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Any anesthetic intervention for patchy or asymmetric block
Tidsramme: 5 min
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The anesthetic record will be reviewed for any interventions done.
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5 min
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Number of manual epidural top ups
Tidsramme: 5 min
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The number of top ups given by nurses or physicians manually will be recorded from the chart.
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5 min
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Number of PCEA (patient controlled epidural analgesia) boluses delivered
Tidsramme: 5 min
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Number of PCEA (patient controlled epidural analgesia) boluses delivered will be collected from the chart.
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5 min
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Duration of epidural analgesia
Tidsramme: 5 min
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Time of epidural placement to delivery or placement to top up for caesarean delivery.
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5 min
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Quality of analgesia questionnaire - 1st stage
Tidsramme: 5 min
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Quality of analgesia during first stage as defined by the patient on a VNRS (verbal numerical rating scale) 0-10 : On a scale from 0-10 (where 0 is not at all and 10 is the best ever), how well did your epidural work from the start of your epidural until you were fully dilated? |
5 min
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Quality of analgesia questionnaire - 2nd stage
Tidsramme: 5 min
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Quality of analgesia during second stage as defined by the patient on a VNRS (verbal numerical rating scale) 0-10: On a scale from 0-10 (where 0 is not at all and 10 is the best ever), how well did your epidural work from you were fully dilated until the delivery of your baby? |
5 min
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Samarbejdspartnere og efterforskere
Publikationer og nyttige links
Datoer for undersøgelser
Studer store datoer
Studiestart (Faktiske)
Primær færdiggørelse (Faktiske)
Studieafslutning (Faktiske)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- 21-07
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
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Kliniske forsøg med Fødselssmerter
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HaEmek Medical Center, IsraelAfsluttet
-
Kaplan Medical CenterAfsluttet
-
Hospital Universitario La PazAfsluttetLabor Epidural AnalgesiSpanien
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Istanbul UniversityAktiv, ikke rekrutterende
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Ain Shams UniversityUkendtLabor Stage, TredjeEgypten
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Menoufia UniversityRekruttering
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University Hospital of the West IndiesAfsluttetLabor Stage, FirstJamaica
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University of LeedsNational Institute of Academic Anaesthesia (NIAA), UK; Obstetric Anaethetists...UkendtGraviditet | Arbejdskraft | Epidural blokering | Primigravida LaborDet Forenede Kongerige
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Kayseri Education and Research HospitalAfsluttet
Kliniske forsøg med color flow Doppler ultrasonography
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Samsun Education and Research HospitalAfsluttet
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Samsun Education and Research HospitalAfsluttetRegional anæstesiKalkun
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NYU Langone HealthTrukket tilbage